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Opioid Development Strategies In Pediatrics To Get FDA Advisory Panel Help

 
• By Michael Cipriano

While FDA has long required pediatric analgesic studies, very few sponsors have managed to complete them, mainly due to enrollment challenges; advisory committees will offer recommendations on other designs that may bring a more successful result.

Three of FDA’s advisory committees will come together to help the agency shore up its guidelines on pediatric opioid development, with only a few sponsors conducting pediatric analgesic studies in spite of long-time requirements to conduct such studies.

The Division of Anesthesia, Analgesia and Addiction Products (DAAAP) in the Center for Drug Evaluation and Research (CDER) for years...

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Denmark Sets New EU Benchmark With 14-Day Clinical Trial Review Timeline

 
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Denmark is shaking up clinical trial timelines with a new process for reviewing applications for early-phase mono-national trials that is twice as fast as the standard timelines in the EU and the UK.

Clinical Trial Diversity Action Plan Guidance Must Return To US FDA Website, Court Says

 
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HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.

Industry Groups Back EU Life Sciences Strategy As Commission Pledges Clinical Trial Investment

 
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Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.

Pharma Companies Suspecting Clinical Trial Fraud Should Move Quickly, Quietly

 
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Sponsors should investigate signals of possible fraud in a manner that does not raise alarms or else evidence might disappear, UK and US regulators said.

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Kennedy Appears Ill-Informed On Major Pharma Priorities, Creating Unique Lobbying Dynamics

 
• By Sarah Karlin-Smith

The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.

Clinical Trial Diversity Action Plan Guidance Must Return To US FDA Website, Court Says

 
• By Sue Sutter

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.

Industry Groups Back EU Life Sciences Strategy As Commission Pledges Clinical Trial Investment

 
• By Eliza Slawther

Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.